Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

Inclusion Criteria:

1. Male or female of any race and between the ages of 18 and 70 inclusive

2. Clinically diagnosed onychomycosis of the target nail

3. Presence of moderate to severe distal subungual onychomycosis

4. A positive potassium hydroxide(KOH) microscopy test result

5. A positive fungal culture for a dermatophyte

6. Females of childbearing potential must be using a highly effective method of birth
control and be willing to remain on the same method of birth control throughout the
study

7. Good general health as determined by the Investigator based on the subject's medical
history and physical examination

Exclusion Criteria:

1. Clinical significant laboratory abnormalities that would interfere with the conduct
or interpretation of the study or jeopardize subject's safety

2. Subjects with a history of diabetes mellitus

3. Unwilling to refrain from the use of nail cosmetics such as clear and/or colored nail
solutions

4. Females who are nursing, pregnant, or planning a pregnancy during the study

5. Failure to complete the specified washout period(s) for the following topical
medications: Antifungals drugs within 4 weeks; Anti-inflammatory drugs,
corticosteroids, immunomodulators within 2 weeks

6. Failure to complete the specified washout period(s) for the following systemic
medications: Corticosteroids within 2 weeks; Antifungals for treatment of
onychomycosis or any antifungal with known activity against dermatophyte within the
previous 24 weeks or 5 half-lives of the drug, whichever is longer; Immunomodulators
within 4 weeks

7. History of cardiac disease and cardiac arrhythmic activity, or prolonged QT interval

8. Received treatment for any type of cancer within the last 6 months

9. History of any significant disease or disorder that might put subjects at risk by
participating in study or influence results of study

10. Nail or anatomic abnormalities of the toe

11. Positive test for HIV, Hepatitis B or Hepatitis C

12. History of street drug or alcohol abuse

13. Donated or lost blood or participated in a clinical study which involved the
withdrawal of a large volume of blood (500 mL or more), within the last 6-week

14. Participated in any other trial of an investigational drug or device within 30 days
or 5 half-lives of the investigational drug or participation in a research study
concurrent with this study

15. Unable to communicate or cooperate with the Investigator due to comprehension, mental
development, or impaired cerebral function

16. Presence of any underlying disease that the Investigator deems uncontrolled, and
poses a concern for the subjects safety while participating on the study